Evaluation of a Fasting Mimicking Diet

NCT04150159 | Completed

• 1 other identifier: HTI 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to End of Study in endothelial function

  Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers

  7 months

Secondary Outcomes (1)

• Change from Baseline to End of Study in cardiovascular biomarkers

  7 months

Study Arms (2)

Fasting Mimicking Diet (FMD) Arm

EXPERIMENTAL

The ProLon® FMD diet is made up of nut bars, dehydrated soups, tea, olives, kale crackers, electrolyte beverages, and a chocolate crisp bar consumed for 5 days every 30 days for 4 months.

Dietary Supplement: FMD Arm

Mediterranean Diet Arm

ACTIVE COMPARATOR

The Mediterranean diet is based on the traditional foods that people used to eat in countries like Italy and Greece in the 1960s. * Eat every day: vegetables, fruits, nuts, seeds, legumes, potatoes, whole grains, breads, yogurt, dairy, fish/seafood, herbs, spices and extra virgin olive oil. * Eat three or fewer servings each week: poultry, eggs, cheese. * Eat two or fewer servings each week: red meat, potatoes. * Eat two or fewer servings each week: sweets, sodas, processed meat, refined grains, refined oils and other highly processed foods.

Dietary Supplement: FMD Arm

Interventions

FMD Arm DIETARY_SUPPLEMENT

ProLon Fasting Mimicking Diet Plan

Fasting Mimicking Diet (FMD) Arm; Mediterranean Diet Arm

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index equal to or greater than 28
• EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
• Pregnant females
• Any cancer within the past 5 years
• Documented myocardial infarction within past 5 years
• Documented cerebrovascular accident within past 5 years
• Chronic steroid use (longer than 45 consecutive days
• Type I insulin-dependent diabetes mellitus

Sponsors & Collaborators

• Hypertension Institute, Nashville: lead
• L-Nutra Inc: collaborator

Study Sites (1)

Hypertension Institute

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 4, 2019
• Study Start: March 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)